A phase II study to evaluate the safety and efficacy of OQL011 on VEGFR inhibitor-associated hand-foot-skin reaction in cancer patients.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. TPS12132-TPS12132
Author(s):  
Mario E. Lacouture ◽  
Milan J. Anadkat ◽  
Omkar Subhash Marathe ◽  
Nicholas J. Vogelzang ◽  
Elaine Tat Lam ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Signaling Pathways ◽  
Skin Reaction ◽  
Vehicle Control ◽  
Life Questionnaire ◽  
Safety And Efficacy ◽  
Patient Reported ◽  
Hand Foot Skin Reaction ◽  
Dose Levels

TPS12132 Background: Hand-Foot Skin Reaction (HFSR) is frequently associated with the use of multi-targeted tyrosine kinase inhibitors of the vascular endothelial growth factor receptor (VEGFRi) such as cabozantinib, regorafenib, sunitinib, and lenvatinib. HFSR affects the skin on the palms and soles and is manifested as edema, erythema, hyperkeratosis, and bullae, leading to a decrease in quality of life and interruptions in dosing. The incidence of HFSR differs among VEGFRi, ranging from 5-60% (all grades) and 1-18% (grade 3). To date, there is no FDA approved treatment for HFSR, and marginal benefit has been shown with topical urea or steroids. Although not fully elucidated, the pathogenesis of HFSR has been associated with impaired vascular repair mechanisms, caused by inhibition of VEGF signaling pathways. We hypothesize that topical stimulation of VEGFR through OQL011 will decrease the severity of HFSR symptoms via local upregulation of the VEGF/VEGFR related signaling pathways. Methods: NCT04088318 is a phase 2, double-blind, randomized controlled trial to evaluate the safety and efficacy of OQL011 compared to vehicle control in the treatment of moderate to severe HFSR in patients on VEGFRi therapy. Eligible patients will have ≥ grade 2 palmar plantar erythrodysesthesia (PPE). The study is expected to enroll 112 patients in two parts. In the first part, 42 patients will apply 0.2% OQL011 topical ointment or vehicle control (2:1 randomization) TID for six weeks. In Part 2, 70 subjects will be randomized into two additional dose levels or vehicle control in a 2:2:1 ratio. The two dose levels selected will be based on the efficacy and safety results of Part 1. The primary efficacy endpoint is improvement of NCI CTCAE v5.0 PPE to grade ≤1 by week 3. Photographs of the affected areas will be taken at Day 0, 7, 14, 21 and 42 timepoints. Superiority test will be performed to compare treatment groups, and the exposure-response relationship will be explored. In addition, an investigator global assessment (IGA) for HFSR will be used in this trial to specifically assess skin recovery and is proposed to be a new evaluation tool. The validity of IGA criteria will be evaluated by assessing the inter-rater and intra-rater reliability. The correlation between IGA, NCI CTCAE v5.0 for PPE, and patient reported outcomes including Visual Analog Scale of Pain, Hand-foot Quality of Life questionnaire will also be evaluated. This study began enrolling patients in December 2019 and is ongoing. Clinical trial information: NCT04088318.

scholarly journals The Hand‐Foot Skin Reaction and Quality of Life Questionnaire: An Assessment Tool for Oncology

2015 ◽  
Vol 20 (7) ◽  
pp. 831-838 ◽  
Author(s):  
Roger T. Anderson ◽  
Karen N. Keating ◽  
Helen A. Doll ◽  
Fabian Camacho
Keyword(s):  
Quality Of Life ◽  
Skin Reaction ◽  
Assessment Tool ◽  
Life Questionnaire ◽  
Quality Of Life Questionnaire ◽  
Hand Foot Skin Reaction

scholarly journals Magnesium level correlation with clinical status and quality of life in women with hormone related conditions and pregnancy based on real world data

2021 ◽  
Vol 11 (1) ◽  
Author(s):  
Svetlana Orlova ◽  
Galina Dikke ◽  
Gisele Pickering ◽  
Eliso Djobava ◽  
Sofya Konchits ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Clinical Status ◽  
High Response Rate ◽  
World Health ◽  
Life Questionnaire ◽  
Real World Data ◽  
World Health Organization Quality ◽  
Patient Reported ◽  
Health Organization

AbstractThis study was aimed to assess the effectiveness of magnesium (Mg)-vitamin B 6 replenishment and its correlation with clinical status in pregnant women (PW), and quality of life in women with hormone-related conditions (HRCW) and hypomagnesemia (HME). Data collected in four observational studies were pooled and analysed. All women received Mg supplementation for 4 weeks. The proportion of women with normalized Mg level, and the correlation between serum Mg dynamics and number of symptoms/complaints (PW) or changes in World Health Organization quality of life questionnaire scores (WHOQOL; HRCW) were evaluated. 869 PW and 957 HRCW were included in the study. Normalization of serum Mg level to ≥ 0.66 mmol/L occurred in 92.1% of PW and 78.4% of HRCW, and to ≥ 0.8 mmol/L in 73.8% and 58.9%, respectively. Mg normalization was accompanied by a median decrease of 1 symptom and 1 complaint in PW. Serum Mg level increase by 0.1 mmol/L was associated to significant changes in the WHOQOL scores in HRCW. Treatment of HME with the Mg for approximately 4 weeks provided a high response rate of Mg serum level, was associated with an improvement in symptom severity and complaints in PW, and WHOQOL score in HRCW. A 0.8 mmol/L cut-off appeared to be more relevant in terms of patient-reported outcomes.

scholarly journals Factors associated with depression and the relationship to quality of life among Saudi women with breast cancer

2020 ◽  
Vol 11 (4) ◽  
pp. 43
Author(s):  
Monefah Al-Shammari ◽  
Amani Khalil
Keyword(s):  
Breast Cancer ◽  
Quality Of Life ◽  
Life Questionnaire ◽  
Primary Therapy ◽  
Convenience Sample ◽  
Saudi Women ◽  
Patient Reported ◽  
Eortc Qlq ◽  
The Relationship

Background and objective: Breast cancer is the most common malignancy among women worldwide, diagnosis and treatment and the months following primary therapy associated with different psychological symptoms that affect quality of life (QoL) in most women with breast cancer. The aim of this study was to identify the relationship between depression and quality of life QoL among Saudi women with breast cancer.Methods: Design: This is a descriptive, cross-sectional study. Methods: A convenience sample of 370 women with breast cancer was recruited from the out-clinic in King Faisal Specialist Hospital \& Research Center (KFSH&RC). Data were collected using self-report tools derived from the Patient-Reported Outcomes Measurement Information System (PROMIS) Emotional Distress-Depression-Short Form; the EORTC quality of life questionnaire (QLQ) (EORTC QLQ-C30, v.3.0 and EORTC QLQ-BR23); and from the Demographic and Clinical Data Sheet.Results: The correlation between depression and global health status with functioning subscales for the women was negative (Pearson’s r = -.357, p < .001; r = -.368, p < .001); whereas a positive correlation was found between depression and symptom subscales, together with its items.Conclusions: This study shows that depression is associated with QoL among Saudi women diagnosed with breast cancer. Therefore, depression affects upon QoL among the breast cancer population. However, enhancement of mental health statuses and psychological interventions helps to reduce the severity of depression and improves health related QoL among this population.

scholarly journals A systematic review of patient-reported outcome measures (PROMs) in cystic fibrosis

BMJ Open ◽  
2020 ◽  
Vol 10 (10) ◽  
pp. e033867
Author(s):  
Irushi Ratnayake ◽  
Susannah Ahern ◽  
Rasa Ruseckaite
Keyword(s):  
Quality Of Life ◽  
Cystic Fibrosis ◽  
Outcome Measures ◽  
Patient Reported Outcome Measures ◽  
Patient Reported Outcome ◽  
Cochrane Library ◽  
Life Questionnaire ◽  
Health Measurement ◽  
Patient Reported

BackgroundTo determine patient-reported outcome measures (PROMs) which may be suitable for incorporation into the Australian Cystic Fibrosis Data Registry (ACFDR) by identifying PROMs administered in adult and paediatric cystic fibrosis (CF) populations in the last decade.MethodsWe searched MEDLINE, EMBASE, Scopus, CINAHL, PsycINFO and Cochrane Library databases for studies published between January 2009 and February 2019 describing the use of PROMs to measure health-related quality of life (HRQoL) in adult and paediatric patients with CF. Validation studies, observational studies and qualitative studies were included. The search was conducted on 13 February 2019. The COnsensus-based Standards for the selection of health Measurement INstruments Risk of Bias Checklist was used to assess the methodological quality of included studies.ResultsTwenty-seven different PROMs were identified. The most commonly used PROMs were designed specifically for CF. Equal numbers of studies were conducted on adult (32%, n=31), paediatric (35%, n=34) and both (27%, n=26) populations. No PROMs were used within a clinical registry setting previously. The two most widely used PROMs, the Cystic Fibrosis Questionnaire—Revised (CFQ-R) and the Cystic Fibrosis Quality of Life Questionnaire (CFQoL), demonstrated good psychometric properties and acceptability in English-speaking populations.DiscussionWe found that although PROMs are widely used in CF, there is a lack of reporting on the efficacy of methods and timepoints of administration. We identified the CFQ-R and CFQoL as the most suitable for incorporation in the ACFDR as they captured significant effects of CF on HRQoL and were reliable and valid in CF populations. These PROMs will be used in a further qualitative study assessing patients’ with CF and clinicians’ perspectives toward the acceptability and feasibility of incorporating a PROM in the ACFDR.PROSPERO registration numberCRD42019126931.

scholarly journals Angioedema quality of life questionnaire (AE-QoL) - interpretability and sensitivity to change

2019 ◽  
Vol 17 (1) ◽  
Author(s):  
Kanokvalai Kulthanan ◽  
Leena Chularojanamontri ◽  
Chuda Rujitharanawong ◽  
Puncharas Weerasubpong ◽  
Marcus Maurer ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Convergent Validity ◽  
Characteristic Curve ◽  
Intraclass Correlation ◽  
Life Questionnaire ◽  
Sensitivity To Change ◽  
Validity And Reliability ◽  
Distribution Method ◽  
Patient Reported

Abstract Background The Angioedema Quality of Life (AE-QoL) is the first patient reported outcome measure developed for the assessment of quality of life (QoL) impairment in patients with recurrent angioedema (RAE). This study aimed to evaluate the clinimetric properties of the AE-QoL in Thai patients and to establish categories of QoL impairment assessed by the AE-QoL. Methods The validated Thai version of the Dermatology Life Quality Index (DLQI) and Patient Global Assessment of Quality of Life (PGA-QoL) were used to comparatively evaluate the Thai version of AE-QoL. Spearman correlations between the Thai AE-QoL and two other standard measurements (DLQI and PGA-QoL) were investigated to determine convergent validity. The Thai DLQI and PGA-QoL were used to categorize patients according to their QoL. Known-group validity of the Thai AE-QoL was later analyzed. The reliability of the Thai AE-QoL was investigated using Cronbach’s alpha and intraclass correlation. Three different approaches including the distribution method, receiver operating characteristic curve analysis, and the anchor based-method were used for the interpretability. Results A total of 86 patients with RAE with a median age of 38.0 ± 15.1 years (range 18–76) were enrolled. Of those, 76 patients (88%) had RAE with concomitant wheals, and 10 patients (11.6%) had RAE only. The AE-QoL assessed RAE-mediated QoL impairment with high convergent validity and known-groups validity, high internal consistency and test-retest reliability, and good sensitivity to change. Although the AE-QoL did not differentiate between patients with moderate and large effect as measured by PGA-QoL or DLQI in this study, AE-QoL total values of 0–23, 24 to 38, and ≥ 39 could define patients with “no effect”, “small effect”, and “moderate to large effect” of RAE on their QoL, respectively. Conclusions This study supports the validity and reliability of the Thai version of the AE-QoL, which is a very different language from the original version. Categories allow to classify the effect of RAE on patients’ QoL as “none”, “small”, and “moderate to large”. Further studies are needed to confirm the applicability of AE-QoL in other Asian populations”.

scholarly journals Impact of Short-Stay Urethroplasty on Health-Related Quality of Life and Patient’s Perception of Timing of Discharge

2015 ◽  
Vol 2015 ◽  
pp. 1-5 ◽  
Author(s):  
Henry Okafor ◽  
Dmitriy Nikolavsky
Keyword(s):  
Quality Of Life ◽  
Life Questionnaire ◽  
Short Stay ◽  
Health Related Quality ◽  
Severe Problem ◽  
Patient Reported ◽  
Related Quality ◽  
Health Related ◽  
Patient’S Perception

Objective.To evaluate health-related quality of life in patients after a short-stay or outpatient urethroplasty.Methods.Over a 2-year period a validated health-related quality-of-life questionnaire, EuroQol (EQ-5D), was administered to all patients after urethroplasty. Postoperatively patients were offered to be sent home immediately or to stay overnight. Within 24 hours after discharge they were assessed for mobility, self-care, usual activities, pain or discomfort, and anxiety and depression. An additional question assessing timing of discharge was added to the survey. Clinical and operative characteristics were examined.Results.Forty-eight patients after anterior urethroplasty completed the survey. Mean age and mean stricture length were 51.6 years (21–78) and 60 mm (5–200 mm), respectively. Most etiologies were idiopathic (50%n= 24), trauma (19%,n= 9), and iatrogenic (19%,n= 9). Forty-one patients (85%) stayed overnight, while 7 patients (15%) chose to be discharged the same day. Overall, ninety-six percent were discharged within 23 hours of surgery. In the short-stay and the outpatient cohorts, 90% and 86%, respectively, felt they were discharged on time. No patient reported a severe problem with postoperative pain or mobility.Conclusions.The majority of patients discharged soon after their procedure felt that discharge timing was appropriate and their health-related quality of life was only minimally affected.

scholarly journals The Prognostic Value for Survival of Patient-Reported Outcomes in Hematological Malignancies: A Systematic Review

Blood ◽  
2016 ◽  
Vol 128 (22) ◽  
pp. 4793-4793
Author(s):  
Avrita Campinha-Bacote ◽  
Peter C Trask ◽  
Fabio Efficace
Keyword(s):  
Quality Of Life ◽  
Prognostic Value ◽  
Patient Reported Outcomes ◽  
Hematological Malignancies ◽  
Multivariate Analyses ◽  
Life Questionnaire ◽  
Quality Of Life Questionnaire ◽  
Patient Reported ◽  
Pre Treatment

Abstract Introduction: Patient-reported outcomes (PROs) are now critical to more comprehensively evaluate treatment outcomes in oncology. There is convincing evidence indicating that, similarly to traditional biomarkers, PROs may also predict survival outcomes. This systematic review examined state of the art literature on the prognostic value of PROs for survival in hematological malignancies. Methods: We searched PubMed and Google Scholar from 2000-2016 for studies assessing the predictive relationship between PROs and overall survival (OS) in Acute Myelogenous Leukemia (AML), Chronic Lymphocytic Lymphoma (CLL), Diffuse Large B-Cell Lymphoma (DLBCL), indolent Non-Hodgkin's Lymphoma (iNHL), Follicular Lymphoma (FL), marginal Zone Lymphoma (mZL), Myelodysplastic Syndrome (MDS), and Multiple Myeloma (MM). Search terms included but were not limited to: quality of life, physical functioning, predictive/prognostic, survival, patient-reported outcomes, and fatigue. Studies were excluded if they did not use multivariate analyses, did not examine OS as an endpoint, were case reports, did not report results for PROs, were reported in an abstract only, or used only clinician-reported outcomes as a predictor. A pre-defined data extraction form (DEF) was used to assess the following data from each article: disease, sample size, demographics, type of PRO measures included, clinical parameters included as predictors, type of analysis, and outcomes assessed. Results: 223 articles were reviewed of which 13 met the inclusion criteria (6 AML/MDS, 3 MM, 2 aggressive lymphomas, 1 mixed heme diagnoses, and 1 DLBCL). PROs in these studies were captured with the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Core30 (EORTC QLQ-C30) or the EORTC myeloma module 24 item (MY24), a health-related quality of life questionnaire for patients with myelodysplastic syndromes (QOL-E), Functional Assessment of Cancer Treatment (FACT) or Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F), and the MD Anderson Symptom Inventory (MDASI). PROs that were independently associated with OS in multivariate analyses from the different studies were: physical function, fatigue, pain, difficulty with strenuous activity, and impaired physical performance in AML patients; physical function and fatigue in MM; fatigue in MDS; global/total QOL and functional well-being in aggressive lymphomas; drowsiness in a mixed group of heme diagnoses; and global QOL, function, and symptoms/signs in DLBCL (see Table). Baseline PROs were obtained following diagnosis of de novo or relapsed disease in 3 studies, within 6 months of registration in 1 study, and prior to any treatment in 6 studies. Conclusions: PROs related to physical functioning, fatigue, and performance were the most common predictors of OS in hematological malignancies and remained significant indicators even after accounting for clinical variables. This review highlights the prognostic value of PROs in both newly diagnosed and relapsed patients, and argues for their use in clinical decision-making and risk assessment at the time of diagnosis and pre-treatment. It also raises the question of how baseline PROs should be used in assessing new treatments within clinical trials in order to identify patients who may respond better to treatments or be in need of pre-treatment adjuvant therapy. Table Table. Disclosures Campinha-Bacote: Genentech, Inc.: Employment. Trask:Genentech, Inc.: Employment, Equity Ownership. Efficace:Lundbeck: Research Funding; Seattle Genetics: Consultancy; Bristol Myers Squibb: Consultancy; TEVA: Consultancy, Research Funding.

scholarly journals Validating an Instrument for Direct Patient Reporting of Distress and Chemotherapy-Related Toxicity among South African Cancer Patients

Cancers ◽  
2021 ◽  
Vol 14 (1) ◽  
pp. 95
Author(s):  
Charmaine L. Blanchard ◽  
Keletso Mmoledi ◽  
Michael H. Antoni ◽  
Georgia Demetriou ◽  
Maureen Joffe ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Construct Validity ◽  
Cancer Patients ◽  
South African ◽  
Pearson Correlation ◽  
Performance Status ◽  
Summary Score ◽  
Life Questionnaire ◽  
Patient Reported

Patient-reported outcome measures (PROM) for monitoring treatment toxicity improve quality of life (QoL) and clinical outcomes. However, no such PROMs exist for sub-Saharan African cancer patients. We aimed to validate the Patient Reported Symptoms-South Africa (PRS-SA) survey, a novel PROM for measuring distress and chemotherapy-related symptoms in South African cancer patients. We enrolled patients at the oncology clinic at Charlotte Maxeke Hospital, Johannesburg. At three separate visits, participants simultaneously completed the PRS-SA survey and several previously validated questionnaires. We constructed a receiver operator characteristics curve for distress levels predicting a Hospital Anxiety and Depression Scale (HADS) score ≥15. We evaluated construct validity for symptom items by comparing severity to the EORTC Core Quality of Life Questionnaire (QLQ-C30) summary score (Pearson correlation tests) and ECOG performance status (Mann–Whitney U tests). We assessed symptom item responsiveness by comparing change in severity to change in QLQ-C30 summary score and comparing standardized mean scores with negative, no, or positive change on the Global Impression of Change (GIC) questionnaire (Jockheere–Terpstra trend test). Overall, 196 participants with solid tumors completed instruments. A distress score of 4 had 82% sensitivity and 55% specificity for clinical depression/anxiety. All symptom items showed construct validity by association with either QLQ-C30 score or performance status (highest p = 0.03). All but cough showed responsiveness to change in QLQ-C30 score (highest p = 0.045). In South African cancer patients, the PRS-SA’s stress scale behaves similarly to the distress thermometer in other populations, and the symptom items demonstrated construct validity and responsiveness. Of note, 46% and 74% of participants who completed the PRS-SA in English or isiZulu, respectively, required assistance reading half or more of the instrument.

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